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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Namesystem, test, automated, antimicrobial susceptibility, short incubation
Regulation Number866.1645
Applicant
Abbott Laboratories
100 abbott park road
dept 9va ap6c-2
abbott park, IL 60064-3500
PMA NumberN50525
Supplement NumberS013
Date Received03/23/1987
Decision Date07/16/1987
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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